Clinical Outcomes of Immediate Implant Placement and Early Implant Placement

Clinical Outcomes of Immediate Implant Placement and Early Implant Placement: a Randomized Controlled Clinical Trial

Immediate implant placement (IIP) has been an attractive treatment concept for both patients and clinicians due to reduced surgical interventions and total treatment span. Although soft-tissue alterations or midfacial recession have been demonstrated in previous studies, recent studies have reported positive result following IIP with the modification of surgical interventions. However, high-quality evidence (≥Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of IIP with early implant placement (type 2) is limited.

Study Overview

• Status: Unknown
• Conditions: Tooth Diseases; Tooth Fractures
• Intervention / Treatment: Procedure: tooth extraction; Procedure: Implant placement; Procedure: Bone augmentation; Procedure: Coronally repositioned flap

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junyu Shi, Phd; Phone Number: 8653315299; Email: sakyamuni_jin@163.com

Study Locations

• China
  • Shanghai, China, 200011
    • Recruiting
    • Shanghai NinthPeoples' Hospital
    • Contact: Xiao Zhang, Master; Phone Number: 8623271699

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age ≧18 years
• single hopeless teeth in anterior maxilla
• enough apical bone volume to achieve primary stability (>4mm)

Exclusion Criteria:

• active periodontoal infection
• incomplete buccal bone plate
• unwilling to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Immediate implant placement; Implants are placed immediately after extraction	Procedure: tooth extraction; Under local anesthesia, tooth will be extracted atraumatically.; Procedure: Implant placement; Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.; Procedure: Bone augmentation; Bone substitute will be used to augment or maintain the bone contour.
PLACEBO_COMPARATOR: Early implant placement; Implants are placed 4-8 weeks after extraction	Procedure: tooth extraction; Under local anesthesia, tooth will be extracted atraumatically.; Procedure: Implant placement; Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.; Procedure: Bone augmentation; Bone substitute will be used to augment or maintain the bone contour.; Procedure: Coronally repositioned flap; After periosteal releasing incision, mucoperiosteal flap will be sutured at a more coronally position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Midfacial recession	Recession of midfacial gingival level before extraction and 1-year follow-up	1-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Papillae recession	Recession of papillae before extraction and 1-year follow-up	1-year follow-up
marginal bone loss	marginal bone level between crown delivery and 1-year follow-up	1-year follow-up
Probing depth	Probing depth between crown delivery and 1-year follow-up	T2:crown delivery, T3: 1-year follow-up
Bleeding on probing %	Bleeding on probing % between crown delivery and 1-year follow-up	T2:crown delivery, T3: 1-year follow-up
Pink esthetic score		T2:crown delivery, T3: 1-year follow-up
Visual Analogue Scale assessement	Visual Analogue Scale on post-operative pain, esthetics and function	T1: immediately after surgery,T2:crown delivery, T3: 1-year follow-up

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2019
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: July 7, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (ACTUAL): July 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Injuries; Tooth Diseases; Tooth Fractures
• Other Study ID Numbers: 136-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No